Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

No text entered.

Reporting Groups

Description

Control Group

EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day1: 500 ml, day2: 1000 ml, day3: 1500 ml of EN dependant on gastrointestinal tolerance (gastric residue volume more than 500ml). Nutritional products as currently used in our institution.

In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.

SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Control gr

EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day1: 500 ml, day2: 1000 ml, day3: 1500 ml of EN dependant on gastrointestinal tolerance (gastric residue volume more than 500ml). Nutritional products as currently used in our institution.

In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.

SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).

Reporting Groups

Description

Control gr

EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.

In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.

SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line.

Total Energy Intake During the Intervention Period , Between Day 4 and Day 8.

Measure Description

Percentage of energy target; in the SPN group the goal was to achieve 100% of the energy target during intervention (day 4 to day 8.The energy target was measured by indirect calorimetry in 198 patients of 305(65%),otherwise energy target was calculated by 25 kcal per kg of ideal body weight for women and 30 kcal per kg of ideal body weight for men and anamnestic body weight was used for patients with a body mass index of 20 kg/m2 or lower.

Time Frame

5 days

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).

Reporting Groups

Description

Control gr

EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.

In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.

SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line.

Measured Values

Control gr

SPN Group

Number of Participants Analyzed
[units: participants]

152

153

Total Energy Intake During the Intervention Period , Between Day 4 and Day 8.
[units: % of energy target]Mean ± Standard Deviation

77
± 27

103
± 18

No statistical analysis provided for Total Energy Intake During the Intervention Period , Between Day 4 and Day 8.

Limitations of the study, such as early termination leading to small numbers of participants
analyzed and technical problems with measurement leading to unreliable or uninterpretable data

The trial was limited by the fact that it was not double blinded by design. However, the risk of bias was reduced because the investigators worked independently from the physicians in charge of the patients.